FDA 510(k)

KATOR Suture Anchor

K-Number: K162386 · 2016-10-25

Decision Date2016-10-25

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

KATOR Suture Anchor is a medical device manufactured by Kator, LLC. It received FDA 510(k) clearance on 2016-10-25 under approval number K162386. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KATOR Suture Anchor?

KATOR Suture Anchor is a medical device that received FDA 510(k) clearance on 2016-10-25. It is manufactured by Kator, LLC. The 510(k) number is K162386.

When was KATOR Suture Anchor approved by the FDA?

KATOR Suture Anchor received FDA 510(k) clearance on 2016-10-25, under approval number K162386.

What company makes KATOR Suture Anchor?

KATOR Suture Anchor is manufactured by Kator, LLC.

What is the FDA product code for KATOR Suture Anchor?

The FDA product code for KATOR Suture Anchor is MBI.

Other Devices by Kator, LLC

K173269KATOR Suture Anchor

Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K161033AFX Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL K160655OrthoButton CLRiverpoint Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.